Bioanalytical Workshop Generates Question on FDA vs. ICH Guidance

The 13th annual WRIB (Workshop on Recent Issues of Bioanalysis) was held in New Orleans, LA this week and is wrapping up today.  The workshop was well represented by regulators and industry (both from Pharma and CROs), with numerous discussions and topics for the bioanalysis of small and large molecules.  Presentations covered the full spectrum of bioanalysis from recently issued guidance documents (both draft and final), trends in observations from regulatory inspections, and the developments and challenges faced by bioanalytical scientists and laboratories.

Portions of each day of the main workshop were dedicated to presentations and panel discussions from representatives of the US-FDA, Health Canada, EU’s EMA, Japan’s MHLW, Brazil’s ANVISA, UK’s MHRA, France’s ANSM, and Norway’s NoMA.  To nobody’s surprise and as has been the case over the last number of years at the WRIB, the conference room was packed with only standing room remaining when the regulators were making their presentations.

On Monday, prior to the main workshop, a training session titled “Implementation of 2018 FDA BMV Final Guidance LCMS & LBA: Regulatory Inputs and Industry Experiences” was provided to those who registered.  Throughout the day, a number of presentations were provided by both the FDA and industry regarding the FDA’s current guidance document titled “Bioanalytical Method Validation” which came into effective May 2018.  This entire day provided attendees the opportunity to ask questions regarding the guidance document with attendees receiving a certificate for their participation.

As the attendees of the workshop were keenly aware, ICH endorsed the draft guidance M10 titled “Bioanalytical Method Validation” February 26, 2019.  Some of the common questions from attendees throughout the conference focused on: the differences between ICH M10 and the US-FDA guidance document, would the US-FDA make observations for non-compliance with the draft ICH M10 guidance, and what would be fate of the FDA guidance document when ICH M10 becomes effective?

If you or your organization have any questions or are in need of support for any aspect of your bioanalytical studies, please contact David O’Connor at d.oconnor@lachmanconsultants.com.